Global Regulatory Leader — Drug-Device, Late-Stage

Aerogen Pharma; Raleigh (NC); Hybride; USD 210 000 - 350 000; Plein temps

Avantages offerts par ce poste

Relocation assistance

Résumé du poste

Aerogen Pharma seeks a seasoned Global Regulatory Leader to serve as strategic deputy to the SVP of Regulatory Affairs, accountable for multiple development programs and regulatory governance. You will shape global registration strategies and build the future regulatory organization.

You will lead interactions with global authorities, partner with development teams, and influence portfolio strategy to enable successful approvals and launches worldwide.

Qualifications

• Bachelor’s degree in a scientific, medical, engineering, or related discipline.
• Advanced degree such as an MS, PharmD, PhD, MD, or equivalent is preferred.
• 10+ years of progressively responsible regulatory affairs experience in pharma/biotech.
• Demonstrated experience independently leading global regulatory strategy for a development-stage product.

Responsabilités

• Lead global regulatory strategy for multiple development programs and act as strategic deputy to SVP of Regulatory Affairs.
• Represent Regulatory Affairs on cross-functional development, governance, and portfolio teams.
• Translate objectives into integrated regulatory strategies, plans, timelines, and resources.

Connaissances

Cross-functional leadership

Strategic judgment

Executive communication

Matrixed organization

Formation

Bachelor’s degree in scientific field

Advanced degree (MS/PhD/PharmD/MD)

Description du poste

Aerogen Pharma seeks a seasoned Global Regulatory Leader to serve as strategic deputy to the SVP of Regulatory Affairs, accountable for multiple development programs and regulatory governance. You will shape global registration strategies and build the future regulatory organization.

You will lead interactions with global authorities, partner with development teams, and influence portfolio strategy to enable successful approvals and launches worldwide.